Some pumps used in end-stage heart failure caused a buildup of biological material that blocks blood flow from the device to the heart’s aorta. The FDA’s recall affects nearly 14,000 devices.
Category: Medical Devices
FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries
Some pumps used in end-stage heart failure caused a buildup of biological material that blocks blood flow from the device to the heart’s aorta. The FDA’s recall affects nearly 14,000 devices.
Ten Doctors on FDA Panel Reviewing Abbott Heart Device Had Financial Ties With Company
Most of the doctors the FDA tapped to advise it on an Abbott medical device had financial ties to the company. The FDA didn’t disclose the payments.
‘AGGA’ Inventor Testifies His Dental Device Was Not Meant for TMJ or Sleep Apnea
The FDA and Department of Justice are investigating the Anterior Growth Guidance Appliance, or “AGGA.” TMJ and sleep apnea patients have filed lawsuits alleging the device harmed them. Its inventor now says the AGGA was never meant for these ailments.
‘AGGA’ Inventor Testifies His Dental Device Was Not Meant for TMJ or Sleep Apnea
The FDA and Department of Justice are investigating the Anterior Growth Guidance Appliance, or “AGGA.” TMJ and sleep apnea patients have filed lawsuits alleging the device harmed them. Its inventor now says the AGGA was never meant for these ailments.
Deep Flaws in FDA Oversight of Medical Devices, and Patient Harm, Exposed in Lawsuits and Records
Thousands of medical devices are sold, and even implanted, with no safety tests.
Patients Facing Death Are Opting for a Lifesaving Heart Device — But at What Risk?
The HeartMate 3 is considered the safest mechanical heart pump of its kind, but a federal database contains more than 4,500 reports in which the medical device may have caused or contributed to a patient’s death.
Patients Expected Profemur Artificial Hips to Last. Then They Snapped in Half.
The FDA and the manufacturer were alerted to Profemur titanium hips breaking inside U.S. patients as of 2005. It took 15 years to recall the devices. Many fractures could have been avoided.
Thousands Got Exactech Knee or Hip Replacements. Then, Patients Say, the Parts Began to Fail.
In a torrent of lawsuits, patients accuse Florida device maker Exactech of hiding knee and hip implant defects for years. The company denies the allegations.
Feds Launch Criminal Investigation Into ‘AGGA’ Dental Device and Its Inventor
Federal prosecutors have launched a criminal investigation into the Anterior Growth Guidance Appliance, or “AGGA” dental device, following a recent KFF Health News-CBS News investigation, according to a motion filed in federal court.
